NIH Chief 'Stunned' by Embryonic Stem Cell Ruling

WASHINGTON -- Francis Collins, MD, director of the National Institutes of Health (NIH), said Tuesday that he was "stunned" by the preliminary injunction granted by a federal judge who ruled NIH funding of stem cell research violates a federal law barring use of government money to destroy human embryos.

Despite the surprising ruling, researchers who are using embryonic stem cells (ESC) do not have to "step away from the petri dish," Collins told reporters during a telephone briefing.

The recipients of nearly 200 grants -- worth a total of $136 million -- that the NIH has already awarded for ESC research can continue for now, but their chances of receiving funding for advanced stages of their studies are seriously in jeopardy, Collins said.

"This decision has the potential to do serious damage to one of the most promising areas of biomedical research," he said. "And it comes just at the time when we were really gaining momentum."

Jonathan Moreno, PhD, a medical ethicist at the University of Pennsylvania, told MedPage Today that the "radical interpretation" of the law has the potential to wipe out all federal funding for human ESC research.

"I see this as a potential catastrophe in which the millions and millions of dollars that have been allocated to dozens of labs all over the country -- that work will have to stop," said Moreno, who is also a senior fellow at the Washington-based Center for American Progress.

"And it will set us back years. It means that hundreds of scientists, perhaps thousands, will not have jobs. They'll lose a funding source. It's bad. And it's bad for the future of life sciences in America."

U.S. district Judge Royce Lamberth granted an injunction on Aug. 23 to block NIH research monies, ruling that a suit brought by researchers opposed to ESC research had merit and could proceed.

The researchers -- James Sherley, MD, and Theresa Deisher, MD -- both work with adult stem cells, which are derived from umbilical cord blood, adult skin cells, or sources other than embryos. Some researchers argue that adult stem cells can produce the same result without destroying a potential human life.

In March 2009, President Obama issued an executive order that lifted one issued by George W. Bush putting restrictions on the use of embryonic stem cells for research. Bush's order made it illegal to use federal funds for research on embryonic stem cells that were derived after the date he issued his order -- Aug. 9, 2001.

Obama's order legalized research on newer embryonic stem cells, and put the NIH in charge of drafting ethics guidelines for doing so. Federal money may not be used for the actual act of obtaining ESC -- that process must be done with private funds, although the NIH demands the procedure be done ethically, and that it use only embryos left over from in vitrofertilization procedures. The guidelines state that embryos cannot be created specifically for the sake of medical research.

Since Obama's order, the NIH has approved a total of 74 ESC lines to be used in research.

In the current lawsuit, the plaintiffs argued that the Obama policy would shift funds from researchers working with adult stem cells. However, Lamberth's 15-page ruling focused on their second point -- that Obama's policy violates a more than decade-old federal law -- because, he said, there were such strong arguments in favor of it.

Collins said the funding of ESC research hasn't taken money away from adult stem cell research and that the agency still funds about three times as much adult stem cell research as it does research with embryos.

The second argument takes aim at a law passed in 1996 known as the Dickey-Wicker amendment, which prohibits the use of federal funds for "research in which a human embryo or embryos are destroyed, discarded, or knowingly subjected to risk of injury or death greater than allowed for research on fetuses in utero ..."

Lamberth ruled that the prohibition encompasses "all research" involving the embryo. That means that while federal funds aren't directly paying for the destruction on an embryo, the subsequent research that results from the embryo being destroyed violates the Dickey-Wicker amendment.

"ESC research is clearly research in which an embryo is destroyed," Lamberth wrote. "Had Congress intended to limit the Dickey-Wicker to only those discrete acts that result in the destruction of an embryo, like the derivation of ESCs, or to research on the embryo itself, Congress could have written the statute that way," wrote Lamberth.

"This is quite a radical interpretation," Moreno commented.

That interpretation would mean that the Bush administration also violated the Dickey-Wicker amendment by allowing embryonic stem cell lines created before 2001 to be used in research, said Moreno and Collins.

David Stevens, MD, a family physician and the CEO of the Christian Medical Association, praised Lamberth's ruling.

"We've felt for a long time that this is going down the wrong road when you sacrifice one human being for the good of others," Stevens told MedPage Today.

Dr. Stevens, and others who oppose ESC research, say destroying embryos is unnecessary because adult stem cells can produce the same treatments and cures.

However, as Moreno and other ESC supporters counter, ESCs are naturally pluriopotent cells, or a clean slate, and aren't programmed to act as a specific cell in the body, which means an ESC cell could be used to repair damaged tissue anywhere in the human body.

Stevens said that even if a breakthrough cure for a devastating disease, such as diabetes, was developed by using ESCs, the moral question doesn't go away and it would be unfair to ask patients to chose a cure that came from sacrificing a "human life."

Lamberth's ruling allows the case to go forward, and it could be argued in U.S. District Court in Washington. However, Congress could also vote to overturn the Dickey-Wicker amendment or to bring it more in line with Obama's policy on human ESC research.

A spokeswoman for Sen. Tom Harkin (D-Iowa) said Tuesday that the senator -- a support of ESC research -- would convene a hearing on the issue on Sept. 16, after the Senate returns from its summer recess.

Stevens said he doesn't think Congress has the will to make such a politically bold statement months before many members are up for re-election in November. However, such a bill could see movement during the lame-duck session following the elections, he said.

Stevens said he hopes the case goes to court.

"What I would like to see is us in this country pursuing ethical research so we don't sacrifice our most important moral principles," Stevens said.

In the meantime, Collins said everyone at the NIH was scrambling on Tuesday to assure researchers that they don't have to immediately stop their studies, as was the fear on Monday.

The NIH did cancel a Tuesday meeting of experts who were planning to discuss approving new ESC lines. They also pulled 50 grants that were awaiting peer review and froze another 22 that are up for annual renewal at the end of September.

"If [this decision] stands, very promising research will not get done," Collins said.

Tracy Schmaler, a spokeswoman for the Justice Department -- which will deal with the legal aspect of the case -- wrote in an e-mail, "We're reviewing the decision."

Lamberth is a well-known jurist who made headlines during the Clinton administration when he ruled that the deliberations of the healthcare reform group assembled by then First Lady Hillary Clinton were not protected by executive privilege.

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